An assortment of pharmaceutical pills (representative file photo). Specific recalled product: see recall details below. Photo: Michael Nutt / Wikimedia Commons (CC BY-SA 2.0).
Recall Database
Drug & Medication Defects Recalls
This hub groups 252 records where the problem is a drug or medication defect — potency out of spec, a dosage or labeling error, a stability or dissolution failure, or a mix-up that puts the wrong strength in the package. The bulk are FDA drug recalls (212), with 40 CPSC records that carry a genuine drug or medication term.
A drug defect is not always about the pill itself; a failed child-resistant closure or a mislabeled carton lands here too. If you take a prescription or over-the-counter medication that has been recalled, this is one of two hubs to check — the other is Drug & Medical Product Contamination, which covers impurity and sterility problems.
The notices are weighted toward 2025 and 2026. Every row links to the FDA or CPSC notice with the lot numbers and the recall reason.
How this hub is built. This page groups the 252 recall records that 411 Press classifies as Drug & Medication Defects. Each record gets one primary hazard from a fixed, published rule set (taxonomy version 2026-07-28.C2.2); a record can carry secondary hazard tags but appears on only one hub. Regulators in this hub: FDA (212), CPSC (40). These notices were published 2023–2026. This is not an all-time archive — it is the current dataset, drawn from CPSC, FDA, and NHTSA notices captured through late May 2026 (CPSC and NHTSA refreshed May 27, FDA May 28, 2026), and it grows as new notices are ingested. Every row links to the original agency notice. The agency's record is the authority; the hazard grouping is ours.
2026 (151)
- CPSCCritical
Residential Elevators StrikeLock Hoistway Door Locking Device
The elevator's StrikeLock hoistway door locking device can allow the elevator cab to move with a landing door open, posing a risk of serious injury or death due to fall and injury hazards.
- CPSCWarning
Travel Size Afrin® Original Nasal Spray 6 mL Bottles
The 6 mL nasal sprays contain an imidazoline, which must be in child-resistant packaging or meet the labeling requirements for non-complying packaging, as required by the Poison Prevention Packaging Act. The 6 mL nasal spray's packaging is not child-resistant nor bears the required labeling statement, posing a risk of serious injury or illness from poisoning, if the contents are swallowed by young children.
- FDAClass II
Oasis Tears PF
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
- FDAClass II
Similasan
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
- FDAClass II
iVIZIA
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
- FDAClass II
Systane
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- FDAClass II
GenTeal Tears
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- FDAClass II
Optase Dry Eye Intense Drops (Glycerin 0.2%)
Lack of Assurance of Sterility
- FDAClass II
FRESHKOTE LUBRICANT EYEDROPS
Lack of Assurance of Sterility
- FDAClass III
Levocarnitine Injection
Labeling: Missing Label
- FDAClass III
Premier
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
- FDAClass III
busPIRone Hydrochloride Tablets
Subpotent drug
- FDAClass II
Omega-3-Acid
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
- CPSCCritical
Various Brands of Iron-Containing Dietary Supplements
The dietary supplements contain iron, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The packaging of the supplements is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- CPSCCritical
SCUBAPRO Monorail Weight Pockets for BCDs
The D-ring handle that is used to unlock the weight pocket from the Buoyancy Compensator Device (BCD) can detach during use. If this happens, the user will not be able to remove the weight pocket in an emergency, in order to rise to the surface, posing a risk of serious injury or death from a drowning hazard.
- FDAClass II
Desmopressin Nasal Spray
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
- FDAClass III
Lidocaine Wound Gel (Benzalkonium Chloride
Failed PH Specifications
- FDAClass II
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr.
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
- FDAClass II
DELFLEX
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- FDAClass II
DELFLEX
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- FDAClass II
Lidocaine HCl Injection
Lack of Assurance of Sterility
- FDAClass II
Lidocaine HCl injection
Lack of Assurance of Sterility
- FDAClass II
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection
Lack of Assurance of Sterility
- FDAClass II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- FDAClass II
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- FDAClass II
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- FDAClass II
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- FDAClass II
0.9 % SODIUM CHLORIDE IRRIGATION
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- CPSCCritical
TecFlox Hair and Beard Growth Serum Bottles
The hair and beard growth serum contains minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The bottles are not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- CPSCCritical
Tuymec Minoxidil Hair Growth Kits, 5% Minoxidil with Biotin Spray
The hair serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair serum's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- FDAClass II
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
- FDAClass II
Ketamine Hydrochloride Injectable Solution
cGMP deviations.
- FDAClass II
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
- FDAClass II
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
- FDAClass II
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
- FDAClass II
fentaNYL Citrate Injectable Solution
cGMP deviations.
- FDAClass II
fentaNYL Citrate Injectable Solution
cGMP deviations.
- FDAClass II
Label is predominantly green with white lettering in a clear plastic clamshell container.
mislabeled Coconut Date Bites. (product is coconut covered, label is for regular date bites)
- FDAClass II
EPINEPHRINE Injection
Lack of Assurance of Sterility
- FDAClass II
Blemish Spot Treatment (Salicylic Acid) 1%
Failed Stability Specifications
- FDAClass III
Magnesium Chloride
Subpotent drug
- FDAClass II
Fluocinonide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- FDAClass II
Fluocinonide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- FDAClass II
Fluocinonide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- FDAClass II
Artificial Tears Lubricant Eye Drops (glycerin 0.2%
Lack of Assurance of Sterility
- FDAClass II
Discount Drug Mart Food Market
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
- FDAClass II
Discount Drug Mart Food Market
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
- FDAClass II
Vancomycin HCL
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- FDAClass II
Vancomycin HCI
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- FDAClass II
Vancomycin HCI
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- FDAClass II
norepinephrine Bitartrate
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- FDAClass II
norepinephrine Bitartrate
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- FDAClass II
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
- FDAClass II
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
- FDAClass II
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
- FDAClass III
Skin Rehab
Subpotent Drug
- FDAClass III
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216.
Subpotent Drug
- FDAClass III
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt.
Subpotent Drug
- FDAClass II
CUROSURF (poractant alfa)
Lack of Assurance of Sterility
- FDAClass III
POPPING BOBA RTD STRAWBERRY DRAGON F/OOLONG TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
- FDAClass III
POPPING BOBA RTD PEACH OOLONG TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
- FDAClass III
POPPING BOBA RTD MIXED BERRY HIBISCUS TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
- FDAClass III
POPPING BOBA RTD MANGO PASSION FRUIT GREEN TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
- FDAClass II
Meclizine Hydrochloride Tablets
Failed tablet specifications.
- FDAClass II
Lanreotide Injection
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- FDAClass II
Lanreotide Injection
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- FDAClass II
5% Dextrose Injection
Lack of Assurance of Sterility
- FDAClass II
5% Dextrose Injection
Lack of Assurance of Sterility
- FDAClass II
5% Dextrose Injection
Lack of Assurance of Sterility
- FDAClass II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- FDAClass II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- FDAClass II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- FDAClass II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- FDAClass II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- FDAClass II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- FDAClass II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- FDAClass II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- FDAClass II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- FDAClass II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- FDAClass II
0.45% Sodium Chloride Injection
Lack of Assurance of Sterility
- FDAClass II
Semaglutide-Glycine-Cyanocobalamin Injectable
Lack of Assurance of Sterility
- FDAClass II
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Lack of Assurance of Sterility
- CPSCCritical
Tomum Hair Regrowth Treatment with Minoxidil for Men and Women Spray Bottles
The hair serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair serum's bottles are not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- FDAClass II
Ultra Lubricating Eye Drops (polyethylene 400 0.4%
Lack of Assurance of Sterility
- FDAClass II
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%)
Lack of Assurance of Sterility
- FDAClass II
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%)
Lack of Assurance of Sterility
- FDAClass II
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%)
Lack of Assurance of Sterility
- FDAClass II
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%
Lack of Assurance of Sterility
- FDAClass II
EYE DROPS Advanced Relief
Lack of Assurance of Sterility
- FDAClass II
Dry Eye Relief Eye Drops
Lack of Assurance of Sterility
- FDAClass II
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%
Lack of Assurance of Sterility
- FDAClass II
Tirzepatide Inj
Lack of Assurance of Sterility
- FDAClass II
Tirzepatide Inj
Lack of Assurance of Sterility
- FDAClass II
Semaglutide Inj.
Lack of Assurance of Sterility
- FDAClass II
Semaglutide Inj
Lack of Assurance of Sterility
- FDAClass II
Levothyroxine Sodium Tablets USP 150 mcg
Subpotent Drug
- CPSCInfo
Window opening control devices sold as kits or installed on 100 Series casement windows
The window opening control devices can break or detach after accidental or other impact, allowing the window to be opened, posing fall and serious injury hazards.
- FDAClass III
C2O Coconut Water with Pulp (17.5 oz) 15 Pack UPC: 8-50274-00792-8
The outer cardboard box for the canned coconut water has the incorrect Nutrition Facts Panel and Ingredient List, which does not include added sugar (5g per 17.5oz can), while the primary packaging (the can) has the correct Nutrition Facts Panel and Ingredient List.
- FDAClass III
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium
Failed Tablet/Capsule Specifications
- FDAClass II
MAXIMUM
Stability Data Does Not Support Expiry Date.
- FDAClass II
MAXIMUM
Stability Data Does Not Support Expiry Date.
- FDAClass II
FIVE-STAR
Stability Data Does Not Support Expiry Date.
- FDAClass III
Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- FDAClass III
Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- FDAClass II
Midodrine Hydrochloride Tablets
Defective container; inadequately sealed blister packaging.
- FDAClass III
Eptifibatide Injection
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
- FDAClass I
Product label reads in part as "WHITE VEIN ADVANCED ALKALOIDS CHEWABLE TABLETS 225mg 7-Hydroxymitragynine per
A sample of the product revealed the active ingredient is in a quantity greater than the labeled specification.
- FDAClass II
Cetrorelix Acetate for Injection (Kit)
Defective Delivery System: Missing or duplicated needles within the injection kit
- FDAClass II
vancomycin HCl
Lack of Assurance of Sterility
- FDAClass II
vancomycin HCl
Lack of Assurance of Sterility
- FDAClass II
thiamine HCl
Lack of Assurance of Sterility
- FDAClass II
ketamine HCl
Lack of Assurance of Sterility
- FDAClass II
acyclovir sodium
Lack of Assurance of Sterility
- FDAClass II
Pro Numb Tattoo Numbing Spray
cGMP deviations
- FDAClass II
Pro Numb Tattoo Numbing Spray
cGMP deviations
- CPSCCritical
AiTuiTui Pull String Teething Toys
The hair growth serum contains minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The serum bottle is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- CPSCCritical
Viofairy Hair Growth Serum
The serum bottles contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The serum's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- CPSCCritical
Sefudun Hair Growth Serum Kits
The hair growth serum contains minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The serum bottle is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- CPSCCritical
Ultimate Multivitamin+ Dietary Supplement Bottles
The bottles are filled with dietary supplements containing iron, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- FDAClass II
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd.
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
- CPSCCritical
Iristar Minoxidil Spray Bottles
The recalled spray bottles contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- FDAClass II
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
Wipes Plus
CGMP Deviations
- FDAClass II
Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes
CGMP Deviations
- FDAClass II
First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
Dynarex
CGMP Deviations
- FDAClass II
Dynarex
CGMP Deviations
- FDAClass II
Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case
CGMP Deviations
- FDAClass II
Cleansing Towelette (Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
Children's Healthcare of Atlanta
CGMP Deviations
- FDAClass II
BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%)
CGMP Deviations
- FDAClass II
Antimicrobial Alcohol Hand Wipe
CGMP Deviations
- FDAClass II
1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes
CGMP Deviations
- FDAClass II
Thyroid
Subpotent Drug
- FDAClass II
methylprednisolone tablets
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
- CPSCCritical
Ruahouine Hair Growth Serum Bottles
The serum bottles contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The serum's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- CPSCCritical
RootStim Beard Growth Serum, 5% Minoxidil
The beard growth serum contains minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The serum's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- FDAClass II
spicely ORGANIC sumac NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO
Product contains salt and is mislabeled
- FDAClass II
spicely ORGANIC garlic salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR
Product contains salt and is mislabeled
- FDAClass II
spicely ORGANIC celery salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR
Product contains salt and is mislabeled
- FDAClass II
Oxycodone Hydrochloride Tablets
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
- FDAClass II
AQ 120 GFEW
cGMP deviations.
2025 (96)
- FDAClass II
Vista Tears Polyethylene Glycol 400 0.4% w/v
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- FDAClass II
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- FDAClass II
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- FDAClass II
Vista Gel Hypromellose USP 0.3% w/v
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- FDAClass II
CHNaO Fluorescein Sodium Ophthalmic Strips
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- FDAClass II
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- FDAClass II
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- FDAClass II
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt.
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
- FDAClass II
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
- FDAClass III
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint.
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
- FDAClass I
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt.
CGMP Deviations: product found to contain lead.
- FDAClass III
Diclofenac Sodium Topical Gel
Failed PH Specifications
- FDAClass III
traZODONE Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
- FDAClass II
INON ACE Antacid tablets (magnesium aluminosilicate
Failed Disintegration Specifications: above the time expected.
- CPSCCritical
Mamisan Pain Relieving Topical Ointment
The ointment contains lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The ointment's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- CPSCCritical
Feel The Beard Minoxidil Beard Growth Oil for Men
The beard serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair serum's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- FDAClass II
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
- FDAClass II
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
- FDAClass II
ORL Kids Natural Toothpaste
cGMP Deviations
- FDAClass II
ORL Kids Mouthwash
cGMP Deviations
- FDAClass III
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
- FDAClass III
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
- FDAClass III
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
- CPSCCritical
MyOnlyStyler Root Booster Hair Dryers
The handheld hair dryers lack an immersion protection device, which presents a substantial product hazard to consumers, posing the risk of death or serious injury from electrocution or shock if the hair dryers fall into water while plugged in.
- FDAClass II
Ondansetron ODT Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
- FDAClass III
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr.
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- FDAClass III
Carton label: Testosterone Gel 1%
Defective Container - A defect in the side-seal which allows leakage of product.
- FDAClass II
Sertraline Hydrochloride Tablets USP
Defective container - seal not adhering to bottles
- FDAClass II
OraVerse
Defective container: cracked/broken cartridges
- FDAClass II
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
- FDAClass II
darby dental supply
Defective container: cracked/broken cartridges
- FDAClass II
Cook-Walte
Defective container: cracked/broken cartridges
- FDAClass II
Benco dental Graham CHEMICAL CO.
Defective container: cracked/broken cartridges
- FDAClass II
3% Polocaine DENTAL
Defective container: cracked/broken cartridges
- FDAClass II
2% Xylocaine DENTAL with Epinephrine 1:100
Defective container: cracked/broken cartridges
- FDAClass II
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd.
Failed Stability Specifications: Observed OOS results: eg results for colour index
- FDAClass II
WeCare, Zinc Oxide Ointment, Net Wt.
cGMP deviations
- FDAClass II
Wecare Enema
cGMP deviations
- FDAClass II
Wecare Calasoothe, Net wt.
cGMP deviations
- FDAClass II
Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt.
cGMP deviations
- FDAClass II
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt.
cGMP deviations
- FDAClass II
Nivagen, Zinc Oxide Ointment, Net Wt.
cGMP deviations
- FDAClass II
Lanashield Skin Barrier, 4 oz.
cGMP deviations
- FDAClass II
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt.
cGMP deviations
- FDAClass II
Globe Clotrimazole Cream USP
cGMP deviations
- FDAClass II
Globe Clotrimazole Cream, USP, 1 %, Net Wt.
cGMP deviations
- FDAClass II
Dynashield Skin Protectant, Net Wt.
cGMP deviations
- FDAClass II
Dynashield
cGMP deviations
- FDAClass II
Dynagel, Moisturizing Wound Hydrogel, Net Wt.
cGMP deviations
- FDAClass I
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
- FDAClass I
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
- FDAClass II
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
- FDAClass II
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
- FDAClass III
Klarity-C Drops (Cyclosporine) 0.1%
Subpotent Drug
- FDAClass II
Acetaminophen 500mg Caffeine 65mg caplets
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
- FDAClass II
Tirzepatide Injection
Lack of Assurance of Sterility
- FDAClass II
Semaglutide Injection
Lack of Assurance of Sterility
- FDAClass II
Semaglutide Injection
Lack of Assurance of Sterility
- FDAClass II
Semaglutide Injection
Lack of Assurance of Sterility
- FDAClass II
Semaglutide Injection
Lack of Assurance of Sterility
- FDAClass II
HADLIMA (adalimumab-bwwd) injection
Lack of Assurance of Sterility.
- FDAClass II
Haloperidol Lactate Injection
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
- FDAClass II
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50
CGMP Deviations
- FDAClass II
Sea Enzyme Ultra Umbrella Sunscreen SPF 30
CGMP Deviations
- FDAClass II
Karina Daily Moisturizer SPF 25
CGMP Deviations
- FDAClass II
Gabriel Mineral Sunscreen SPF 50
CGMP Deviations
- FDAClass II
Elixir by Coco March Tinted Mineral Sunscreen SPF 50
CGMP Deviations
- FDAClass II
Elixir by Coco March Mineral Sunscreen SPF 50
CGMP Deviations
- FDAClass II
Dr.
CGMP Deviations
- FDAClass II
Doctor.
CGMP Deviations
- FDAClass II
Doctor D.
CGMP Deviations
- FDAClass II
Doctor D.
CGMP Deviations
- FDAClass II
Doctor D.
CGMP Deviations
- FDAClass II
Doctor D.
CGMP Deviations
- FDAClass II
Doctor D.
CGMP Deviations
- FDAClass II
CLEARSTEM YOU ARE SUNSHINE SPF 50
CGMP Deviations
- CPSCCritical
Dissolved Oxygen Test Kits
The recalled test kits contain a bottle of sulfuric acid, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The test kits violate the mandatory standard for child-resistant packaging because the bottle of sulfuric acid is not child-resistant, posing a risk of serious injury or death from poisoning, if the contents are swallowed by young children.
- CPSCCritical
RELIEVE Numbing Cream
The numbing cream contains lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The numbing cream's packaging is not child-resistant, posing a risk of serious injury or death from poisoning, if the contents are swallowed by young children.
- FDAClass II
Fentanyl citrate
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
- FDAClass II
Phenylephrine HCI
CGMP Deviations
- FDAClass III
Espumil
Labeling: Not Elsewhere Classified
- CPSCInfo
Bariatric Fusion Iron Multivitamin Bottles
The recalled multivitamins contain iron, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The recalled packaging of the iron-containing multivitamins violates the federal standard for child-resistant packaging because the bottle caps are not child-resistant, posing a risk of deadly poisoning, if the contents are swallowed by young children.
- CPSCCritical
Hair Dryers sold under the "Remington" brand, model number D3190DCDN
The handheld hair dryers lack an immersion protection device, which presents a substantial product hazard to consumers, posing the risk of death or serious injury from electrocution or shock if the hair dryers fall into water while plugged in.
- CPSCCritical
Séfralls Minoxidil Hair Generation Serum
The hair serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair serum's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
- CPSCInfo
California Gold Nutrition Iron Supplements: Daily Prenatal Multi, Ultamins Women's Multivitamin, and Ultamins Women's 50+ Multivitamin
The recalled dietary supplements contain iron, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The iron-containing dietary supplement packages violate the federal standard for child-resistant packaging because the bottles and blister packs are not child-resistant, posing a risk of deadly poisoning, if the contents are swallowed by young children.
- CPSCCritical
Bliss Hair Dryers
The handheld hair dryers lack an immersion protection device and can cause death or serious injury due to electrocution or shock if the hair dryers fall into water when plugged in. The hair dryers are in violation of federal regulations for hair dryers and present a substantial product hazard.
- CPSCInfo
Safetussin Max Strength Multi-Symptom Cough, Cold and Flu tablets blister packs
The Safetussin over-the-counter cold medicine contains acetaminophen, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The packaging of the products is not child-resistant as a tablet can be pushed through the foil, posing a risk of poisoning if the contents are swallowed by young children.
- CPSCCritical
Mini Travel Hair Dryers
The handheld hair dryers lack an immersion protection device and can cause death or serious injury due to electrocution or shock if the hair dryers fall into water when plugged in. The hair dryers are in violation of the federal regulations and present a substantial product hazard.
- CPSCCritical
LVOE Hair Dryers
The handheld hair dryers lack an immersion protection device and can cause death or serious injury due to electrocution or shock if they fall into water when plugged in. The hair dryers are in violation of the federal regulations and present a substantial product hazard.
- CPSCCritical
Foldable Travel Hair Dryers
The handheld hair dryers lack an immersion protection device that can cause death or serious injury due to electrocution or shock hazards if it falls into water when plugged in. The hair dryers are in violation of the federal regulations and present a substantial product hazard.
- CPSCInfo
NFH Iron SAP, NFH Heme Iron SAP and NFH Prenatal SAP bottles
The recalled dietary supplements contain iron, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.
- CPSCInfo
Benadryl Liquid Elixir, 100 mL bottles
The Benadryl contains diphenhydramine, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The packaging of the products is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.
- CPSCCritical
BD Recon LT Avalanche Transceivers
The metal contact in the switch mechanism of the Recon LT avalanche transceiver can corrode and cause the transceiver to malfunction. If this occurs, the device can turn off and make it impossible to locate a victim in an avalanche, which could result in serious injury or death.
- CPSCCritical
TRUBLUE iQ and TRUBLUE iQ+ Auto Belays
The recalled auto belay device can fail to retract, posing a fall hazard and risk of serious injury or death.
- CPSCWarning
6-in-1 Multi Styler and 5-in-1 Multi Styler Hair Dryers
The handheld hair dryers lack an immersion protection device, posing an electrocution or shock hazard to consumers, if the hair dryers fall into water when plugged in. The CPSC has determined that hair dryers not equipped with the integral immersion protection present a substantial product hazard.
- CPSCWarning
Teckwe Hair Dryer Brushes
The handheld hair dryer brushes lack an immersion protection device, posing an electrocution or shock hazard to consumers if the hair dryer brushes fall into water when plugged in. The CPSC has determined that hair dryers not equipped with the integral immersion protection present a substantial product hazard.
2024 (2)
- CPSCWarning
Tideway High-Speed Hair Dryers
The handheld hair dryers lack an immersion protection device, posing an electrocution or shock hazard to consumers, if they fall into water when plugged in. The CPSC has determined that hair dryers not equipped with the integral immersion protection present a substantial product hazard.
- CPSCCritical
TRUBLUE iQ Auto Belay Devices
The recalled auto belay device can fail to retract, posing a fall hazard and risk of serious injury or death.
2023 (3)
- CPSCInfo
Solaray Liposomal Multivitamins
The recalled dietary supplements contain iron, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.
- CPSCInfo
Ferrous Sulfate (Iron) Enteric-Coated Tablets, 324 mg - 100 Tablet Bottles
The recalled dietary supplements contain iron which must be in child-resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.
- CPSCInfo
SCUBA Diving Buoyancy Compensating Devices OceanPro, Excursion, Hera
The handle for the weight pockets in the Scuba Diving Buoyancy Compensating Device can break during use. If this happens, the user will not be able to dump weight pockets in an emergency to rise to the surface, posing a drowning hazard.